Bacterial Vaginosis - Pipeline Review, H2 2016

 Table of Contents

Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Bacterial Vaginosis Overview 7
Therapeutics Development 8
Pipeline Products for Bacterial Vaginosis - Overview 8
Pipeline Products for Bacterial Vaginosis - Comparative Analysis 9
Bacterial Vaginosis - Therapeutics under Development by Companies 10
Bacterial Vaginosis - Therapeutics under Investigation by Universities/Institutes 11
Bacterial Vaginosis - Pipeline Products Glance 12
Late Stage Products 12
Clinical Stage Products 13
Early Stage Products 14
Bacterial Vaginosis - Products under Development by Companies 15
Bacterial Vaginosis - Products under Investigation by Universities/Institutes 16
Bacterial Vaginosis - Companies Involved in Therapeutics Development 17
Alfa Wassermann S.p.A 17
AmVac AG (Inactive) 18
Evofem, Inc. 19
Osel, Inc. 20
Starpharma Holdings Limited 21
Symbiomix Therapeutics, LLC 22
Bacterial Vaginosis - Therapeutics Assessment 23
Assessment by Monotherapy Products 23
Assessment by Target 24
Assessment by Mechanism of Action 25
Assessment by Route of Administration 26
Assessment by Molecule Type 28
Drug Profiles 30
Amphora - Drug Profile 30
Product Description 30
Mechanism Of Action 30
R&D Progress 30
AMV-100 - Drug Profile 32
Product Description 32
Mechanism Of Action 32
R&D Progress 32
astodrimer - Drug Profile 33
Product Description 33
Mechanism Of Action 33
R&D Progress 33
benzoyl peroxide - Drug Profile 37
Product Description 37
Mechanism Of Action 37
R&D Progress 37
LACTIN-V - Drug Profile 38
Product Description 38
Mechanism Of Action 38
R&D Progress 38
rifaximin - Drug Profile 39
Product Description 39
Mechanism Of Action 39
R&D Progress 39
secnidazole - Drug Profile 43
Product Description 43
Mechanism Of Action 43
R&D Progress 43
Small Molecule for Bacterial Vaginosis and Candidiasis - Drug Profile 45
Product Description 45
Mechanism Of Action 45
R&D Progress 45
subtilosin - Drug Profile 46
Product Description 46
Mechanism Of Action 46
R&D Progress 46
TOL-463 - Drug Profile 47
Product Description 47
Mechanism Of Action 47
R&D Progress 47
Bacterial Vaginosis - Dormant Projects 48
Bacterial Vaginosis - Discontinued Products 49
Bacterial Vaginosis - Product Development Milestones 50
Featured News & Press Releases 50
May 26, 2016: Symbiomix Therapeutics Announces Positive Results from Phase 3 Trial of SYM-1219 for Bacterial Vaginosis, and Pre-NDA Meeting with FDA Supportive of 2016 NDA Filing 50
May 11, 2016: Osel Lead Product LACTIN-V Enters Phase 2b Study to Prevent Recurrence of Bacterial Vaginosis 50
Mar 31, 2016: Evofem Files IND for Evaluation of Prevention of Recurrence of Bacterial Vaginosis 51
Jan 11, 2016: Evofem Holdings Announces Successful Completion of Pre-IND Meeting for Amphora 52
Oct 14, 2015: Additional US Patent granted for VivaGel BV 52
Sep 24, 2015: EU Marketing Approval Granted for VivaGel BV 53
Sep 21, 2015: Symbiomix Therapeutics Presents Data at ICAAC/ICC Demonstrating Oral Pharmacokinetics of Lead Product SYM-1219 Administered With and Without Food 53
Aug 27, 2015: Symbiomix Therapeutics Completes Enrollment in Second Pivotal Trial of SYM-1219 for Bacterial Vaginosis, and Receives FDA Fast Track Designation 54
Aug 06, 2015: Symbiomix Therapeutics' First Pivotal Trial Results for SYM-1219 for Bacterial Vaginosis Presented at IDSOG 55
Jun 09, 2015: Symbiomix Therapeutics Doses First Patient in Confirmatory Phase 3 Pivotal Study of Lead Drug Candidate SYM-1219 for Bacterial Vaginosis 56
May 05, 2015: Symbiomix Therapeutics Announces Positive Results from a Pivotal Phase 2 Trial of SYM-1219 for the Treatment of Bacterial Vaginosis 56
Mar 04, 2015: Symbiomix Therapeutics Studies Show Drug Candidate for Women's Health Infections is Safe and Well-Tolerated 57
Nov 21, 2014: SYM-1219 Chosen as one of the "Top Infectious Disease Projects" to Watch by Therapeutic Area Partnerships 58
Sep 09, 2014: Symbiomix Therapeutics Makes First Corporate Announcement: Completion of Enrollment in a Phase 2 Clinical Trial of SYM-1219 for Bacterial Vaginosis 58
Jul 14, 2014: FDA Grants SPA Agreement for Phase 3 Recurrent BV Trial 59
Appendix 60
Methodology 60
Coverage 60
Secondary Research 60
Primary Research 60
Expert Panel Validation 60
Contact Us 60
Disclaimer 61

List of Tables

Number of Products under Development for Bacterial Vaginosis, H2 2016 8
Number of Products under Development for Bacterial Vaginosis - Comparative Analysis, H2 2016 9
Number of Products under Development by Companies, H2 2016 10
Number of Products under Investigation by Universities/Institutes, H2 2016 11
Comparative Analysis by Late Stage Development, H2 2016 12
Comparative Analysis by Clinical Stage Development, H2 2016 13
Comparative Analysis by Early Stage Development, H2 2016 14
Products under Development by Companies, H2 2016 15
Products under Investigation by Universities/Institutes, H2 2016 16
Bacterial Vaginosis - Pipeline by Alfa Wassermann S.p.A, H2 2016 17
Bacterial Vaginosis - Pipeline by AmVac AG (Inactive), H2 2016 18
Bacterial Vaginosis - Pipeline by Evofem, Inc., H2 2016 19
Bacterial Vaginosis - Pipeline by Osel, Inc., H2 2016 20
Bacterial Vaginosis - Pipeline by Starpharma Holdings Limited, H2 2016 21
Bacterial Vaginosis - Pipeline by Symbiomix Therapeutics, LLC, H2 2016 22
Assessment by Monotherapy Products, H2 2016 23
Number of Products by Stage and Target, H2 2016 24
Number of Products by Stage and Mechanism of Action, H2 2016 25
Number of Products by Stage and Route of Administration, H2 2016 27
Number of Products by Stage and Molecule Type, H2 2016 29
Bacterial Vaginosis - Dormant Projects, H2 2016 48
Bacterial Vaginosis - Discontinued Products, H2 2016 49 

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